Transvaginal system and method for treating female urinary incontinence

ABSTRACT

A pubic bone-mounted urethra stabilization and support system includes a pair of anchors which are affixed to the posterior/inferior pubic bone, sutures attached to the anchors, and a mesh sling which is passed behind and about the urethra and the adjacent endopelvic fascia. The ends of the sling are attached to the anchors by the anchor-mounted sutures. The method includes the steps of accessing the urethra and the pubic bone through a vaginal incision, properly locating and attaching the anchors to the pubic bone, properly locating the sling about the urethra and adjacent endopubic fascia and suturing and tensioning the ends of the sling to the anchors, causing said sling to restore, support and stabilize functional urethral continence anatomy and prevent urethral descent under intraabdominal pressure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 09/111,525,filed Jul. 8, 1998, now U.S. Pat. No. 6,039,686 in the name of S. RobertKovac, entitled A SYSTEM AND A METHOD FOR THE LONG TERM CURE OFRECURRENT URINARY FEMALE INCONTINENCE, and which is incorporated hereinby reference, which in turn is a continuation-in-part of applicationSer. No. 08/820,053, filed Mar. 18, 1997, now abandoned.

BACKGROUND OF THE INVENTION

The invention relates to a system and method for the effective long-termcure of recurrent female urinary incontinence, and more particularly toa urethra stabilization and support system attached to theposterior/inferior pubic bone and a method for accomplishing this inwhich a hypermobile urethra is repositioned in the anatomically properposition.

The problem of recurrent female urinary incontinence, or the inabilityto control urination, is a major and debilitating one affecting millionsof women in the United States alone. One particular type that frequentlyoccurs in women is stress urinary incontinence, which is precipitated bycoughing, straining, or heavy lifting. Mild cases may be treated byexercises involving tightening and relaxing of the perineal and glutealmuscles or by sympathomimetic drug therapy. Severe cases, however, mayrequire surgery to correct the underlying anatomic defect. It is thissurgical correction which is the subject of the present invention.

In general, continence is considered to be a function of urethralsupport and coaptation. For coaptation to successfully prevent or cureincontinence, the urethra must be supported and stabilized in its normalanatomic position. The female's natural support system for the urethrais a hammock-like supportive layer composed of endopelvic fascia, theanterior vaginal wall, and the arcus tendineus (a distal attachment tothe pubic bone). Weakening and elongation of the pubourethral ligamentsand the arcus tendineus fascia pelvis, weakening of the endopelvicfascia and pubourethral prolapse of the anterior vaginal wall, and theircomplex interaction with intraabdominal forces are all suspected to playa role in the loss of pelvic support for the urethra and subsequenthypermobility to an unnaturally low non-anatomic position, leading tourinary incontinence.

Many procedures have been devised to treat urinary incontinence with thegoal of elevating the neck of the bladder to return it to a higherretropubic position. Some involve the creation of a compensatorypubovaginal sling through a variety of needle suspension procedures;others employ a suburethral mesh to act as a compensatory suburethralsling to avoid the possibility that the sutures used in the needlessuspension procedures will easily tear.

Many of the needle suspension procedures involve placing sutures in theendopelvic fascia or the anterior vaginal wall on either side of theurethra and attaching them to fixation sites such as bone and softtissue. Alternatively, the sutures are attached to artificial anchorsplaced within the pelvis, at the superior border of the pubis, or rectusabdominus fascia. A major problem with this type of procedure is thatthe very fascial and muscular support structures that are sutured forsupport are often stretched, damaged, or otherwise deficient to beginwith, and remain so after the procedure. It is therefore difficult toemploy them successfully as reinforcements for surgical repair. Thepubovaginal sling procedure, in which a mesh is placed under the urethrato provide elevation and support of the urethra and bladder neck, isperformed through an abdominal incision, and has enjoyed an excellentsurgical success rate. It is generally preferable for more complicatedcases of recurrent genuine stress urinary incontinence, particularly inpatients who have failed prior surgery, who are obese, or whoselifestyles involve heavy lifting and accompanying increasedintraabdominal pressure. However, problems with voiding disjunction andurinary retention, detrusor instability, and infection and erosion ofsling materials that can lead to urethrovesical and vesicovaginalfistulas are cause for concern. Additionally, because of the abdominalincision, this procedure is more technically challenging, presentsgreater blood loss, longer operative time, and a prolonged postoperativerecovery.

These techniques use a variety of attachment sites for bladder neck andurethral support, such as the superior portion of the pubis, Cooper'sligament, or rectus abdominus fascia. This results in placement of theurethra in an unnaturally high position with respect to its normalanatomical retropubic position so that problems with voiding and urinaryretention frequently arise after the procedure. Further, this abnormalpositioning of the urethra in conjunction with failure of the supportingtissues and poor surgical technique have often led to a recurrence ofincontinence since all of these operations create a compensatoryabnormality rather than restoring the normal anatomy.

A related difficulty that contributes to the unnatural positioning ofthe urethra is that some attachment sites, such as the rectus abdominusfascia, require very long sutures and accompanying difficulty inachieving the proper tension in the sutures. This can result inincreased lateral movement and momentum of the support structures ormesh sling when they are moved due to intraabdominal pressures.

The present invention addresses and corrects these and otherdifficulties by affecting the continence mechanism directly andproviding a predictable and lasting permanent cure for the problem ofrecurrent female urinary incontinence.

It has been found that the key site for control of continence has notbeen heretofore addressed. It has further been found that the urethralhypermobility observed in most incontinent patients is caused by a laxor torn arcus tendineus facie pelvis attachment at its origin near theanterior levator arch in the immediate retropubic position at the siteof the pubourethral ligaments. Repair and reinforcement of this area tostabilize the urethra in its normal position may be equally important asrepair of the endopelvic facie. Therefore, the key site for control ofcontinence is the paraurethral attachments of the pubourethral ligamentsto the sides of the urethra at the intermediate 60% of the urethrallength. This is simulated through the employment of a mesh sling systemwhich supports this site and restores the bladder neck and urethra totheir normal anatomic retropubic position. Additionally, when placed inthis position, the lateral sides of the mesh serve to act aspubourethral ligaments which help to prevent undue descent of theurethra.

It has also been found that although the superior portion of the pubicbone is a functional and secure fixation site for incontinence repair, akey to restoring the urethra to its normal anatomical position is usingthe posterior/inferior border of the pubic bone, not the superiorportion, as the attachment sites for mymesh sling system. In particular,the sling system of the present invention is anchored to the pubic bonenear the point of attachment of the arcus tendineus to the pubic bone.Proper tensioning of my mesh sling system is made easier by using thisportion of the pubic bone as the attachment site, due in part to thefact that shorter sutures and an innovative mesh suturing pattern isused. This serves to avoid the problems heretofore discussed associatedwith an improperly high retropubic positioning of the urethra.

BRIEF SUMMARY OF THE INVENTION

According to the invention there is provided a pubic bone-mountedurethra stabilization and support system and a method for the long termcure of recurrent female urinary incontinence.

The system comprises a pair of anchors which are affixed to theposterior/inferior pubic bone near the point of attachment of the arcustendineus to the pubic bone, sutures attached to the anchors, and asling which is passed behind and about the urethra and the adjacentendopelvic fascia. Ends of the sling are attached to the anchors by theanchor-mounted sutures. In particular, a pair of anchor screws arelocated on either side of the symphysis pubis in the retropubic areaposteriorly and at about 0.5 cm superiorly of the inferior edge of theischial ramus. Sutures connect the anchor screws to the mesh sling. Themesh sling directly supports the urethra by its placement on theendopelvic fascia in the area of the intermediate 60 percent portion ofthe urethra as will be later described in greater detail.

The method includes the steps of accessing said urethra and pubic bone,properly locating and attaching the anchors to the pubic bone, properlylocating the sling about the urethra and suturing and tensioning theends of the sling to the anchors, causing said sling to restore, supportand stabilize functional urethral continence anatomy and preventurethral descent under intraabdominal pressure.

To access the urethra and pubic bone, a pair of divergent incisions aremade, beginning at the posterior urethral fold, in the anterior vaginalwall. This creates a triangular flap to expose the operative field. Caremust be taken to separate the anterior vaginal wall from the adjoiningendopelvic fascia to leave the endopelvic fascia intact. Directvisualization and palpation is next employed to evaluate the integrityof the lateral attachment of the endopelvic fascia to each arcustendineus fascia pelvis, repairing any damage by suturing if necessary.

The pubic bone is next located by palpation. The course of the arcusfrom the ischial spine to the arcus insertion into theposterior/inferior aspect of the pubic bone is palpated to locate theproper site for the anchor screws, which is at either side of thesymphysis pubis in the retropubic area posteriorly and at about 0.5 cmsuperiorly of the inferior edge of the ischial ramus. An anchor screw,which is provided with a pair of permanent sutures, is driven into thepubic bone at this location and set. An identical anchor screw is thendriven into a symmetrically located position on the other side of thesymphysis pubis.

A sling, which can be made of a substantially rectangular patch ofsurgical mesh, is next laid upon the endopelvic fascia such that itslongitudinal edges extend transversely of the urethra which is below theendopelvic fascia. Four permanent sutures are used to transfix the meshalong the lateral borders of the urethra at the edges of the mesh. Thesesutures are so positioned as to create a slight trough-like spacebetween the mesh and the endopelvic fascia and urethra. This spaceprevents undue tension on the urethra by the mesh when the mesh isformed into a sling. The permanent sutures of the anchor screws are thenwoven transversely of the mesh in opposite directions between thelongitudinal edges of the mesh and inset from the transverse mesh edges.These sutures are then bilaterally tied with appropriate tensioning totransform the mesh into a sling.

Finally, any additional necessary repairs, including the sequentialtying of the repair sutures for attaching the endopelvic fascia to thearcus tendineus fascia pelvis, are made. The cut edges of the anteriorvaginal wall are approximated with sutures, and the cul-de-sac andposterior vaginal segment defects are repaired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary midsagittal cross-sectional view of the pelvicregion illustrating the disposition of the urethra, bladder and vaginatogether with neighboring organs in a healthy woman.

FIG. 2 is a fragmentary transverse view generally as seen along the line2—2 of FIG. 1, illustrating the pubic bone, the bladder, the urethra,the arcus tendineus fascia, the endopelvic fascia and the pubourethralligaments.

FIG. 3 is a fragmentary midsagittal cross-sectional view, similar toFIG. 1, and illustrating the prolapse of the urethra against theanterior wall of the vagina.

FIG. 4 is a frontal surgical view of the external female genitalia insurgical preparation with the labia minora in open position exposing thevestibule and the lower vagina of a female patient having the prolapsecondition illustrated in FIG. 3.

FIG. 5 is a fragmentary surgical view, similar to FIG. 4, andillustrates the posterior orifice of the vagina distended by means of avaginal retractor, together with an incision made in the anterior wallof the vagina exposing the fascia tissue covering the urethra.

FIG. 6 is a fragmentary surgical view similar to FIG. 5 and illustratesthe lateral edges of the incision stretched in open position and theplacement of a suture-bearing anchor screw retropubically at theposterior/inferior border of the pubic bone to the left of the pubicsymphysis and within 1 to 2 mm from the insertion of the arcus tendineusfascia pelvis.

FIG. 7 is a fragmentary surgical view, similar to FIG. 6, andillustrates both suture-bearing anchor screws in place in the pubic boneand a rectangular piece of surgical mesh overlying the urethra andsutured adjacent either side of the urethra to the endopelvic fascia.

FIG. 8 is a fragmentary surgical view, similar to FIG. 7, andillustrates the sutures of each anchor screw oppositely threaded throughits respective side of the mesh.

FIG. 9 is a fragmentary surgical view, similar to FIG. 8 and illustratesthe anchor screw sutures being tensioned and tied, bringing the lateraledges of the mesh into conjunction with the anchor screws, forming asling support for the urethra.

FIG. 10 is a fragmentary midsagittal cross-sectional view, similar toFIG. 1, and illustrates the urethra, bladder and neighboring organs of awoman whose urinary prolapse has been corrected by the system of thepresent invention.

FIG. 11 is a fragmentary view of the pubic bone and the urethra, theurethra being supported by the system of the present invention.

FIG. 12 is an elevational view of another embodiment of a surgical meshsling.

FIG. 13 is an elevational view of yet another embodiment of a surgicalmesh sling.

DETAILED DESCRIPTION OF THE INVENTION

Throughout the drawings, like parts have been given like index numerals.Reference is first made to FIGS. 1 and 2. These Figures illustrate thelocation of the urethra and bladder of a healthy, continent female.

The pelvis is generally indicated at 1 in FIGS. 1 and 2. The forwardbony portions of the pelvis 1 a and 1 b (i.e. the pubic bone) are joinedtogether by the pubic symphysis 2. The bladder 3 is located above andbehind the pubic bone 1 a and 1 b. The urethra extends from the bladder3 downwardly to the urinary meatus 5.

The vagina 6 is located behind the bladder and urethra and is surmountedby the uterus 7 which overlies the bladder.

The upper 20 percent of the urethra constitutes the urethra-vesicaljunction 4 a or bladder neck portion. The lowermost 20 percent 4 b ofthe urethra leads to the urinary meatus 5. The intermediate 60 percentof the urethra (shown between index numerals 4 a and 4 b), is providedwith a sphincteric mechanism, and support of this part of the urethra isbelieved to be of key importance for continence. This is the part of theurethra which is subject to the greatest pressure as the result ofprolapse.

Attention is again directed to FIG. 1, and particularly to FIG. 2. Ithas long been understood that female continence is largely a factor ofthe proper support and stabilization of the bladder 3 and urethra 4 intheir normal retropubic state and particularly during coughing,straining and the like. In the healthy, continent female, the urethraand bladder are separated from the extraabdominal area by a hammock-likesupportive layer comprising the web of endopelvic fascia 8 and theanterior vaginal wall 6 a. As is most clearly shown in FIG. 2, the webof endopelvic fascia 8 is attached to the arcus tendineus fascia pelvis9 at the right side of the pelvis (as viewed in FIG. 2) and to the arcustendineus fascia pelvis 10 on the left side of the pelvis (as viewed inFIG. 2). The arcus tendineus fascia pelvis 9 extends from the ischialspine 11 to its insertion in the pubic bone portion 1 a at 12.Similarly, the arcus tendineus fascia pelvis 10 extends from the ischialspine 13 to the insertion of the arcus tendineus fascia pelvis in thepelvic bone portion 1 b, at 14.

The urethra 4 is additionally supported by a pair of pubourethralligaments 15 and 16. Pubourethral ligament 15 is attached to the side ofurethra 4 and extends forwardly to the pubic bone 1 a adjacent theinsertion 12 of the arcus tendineus fascia pelvis 9. In a similarfashion, the pubourethral ligament 16 extends from the opposite side ofthe urethra 4 to the pubic bone 1 b adjacent the insertion 14 of thearcus tendineus fascia pelvis 10. The attachment of the pubourethialligaments to the sides of urethra 4 are located at the above-notedintermediate 60 percent of the urethra.

From the above, it will be apparent that weakening of the endopelvicfascia 8, weakening of the anterior vaginal wall 6 a, weakening of theattachments to the pubic bone and stretching of the pubourethralligaments 15 and 16 can result in urethral hyper-mobility andincontinence. The sling of the present invention not only supports theurethra in its normal position, but also limits urethral descent at thesite of continence control. Since the urethra cannot be elevated abovethe level of attachment of the sling to the inferior/posterior border ofthe pubis, it functions only with increasing intraabdominal pressure toprevent urethral descent.

At this point, the manner in which the system of the present inventionis applied and used will now be described. Reference is first made toFIG. 4 which is a frontal or surgical view of the female genitalia withthe labia minora 17 and 18 parted to reveal the urethral meatus 5 andthe vestibule 19. The opening of the vagina 6 is shown at 6 b. Theanterior wall 6 a of the vagina is also shown. Prolapse of the bladder,the urethra and the anterior wall 6 of the vagina is evidenced by abulging of the vagina (as shown) and the fact that the anterior wall 6 afalls away less steeply than would be the case in a healthy woman.Depending upon the severity of the prolapse, the anterior wall 6 a ofthe vagina may extend through the vaginal opening 6 b.

Reference is now made to FIG. 5. In this Figure the posterior wall ofthe vagina and the adjacent portion of the vaginal opening 6 b aredistended by means of a vaginal retractor 20. A pair of divergentincisions 21 and 22 is made, beginning at posterior urethral fold,indicated at 23. The portion 24 of the anterior vaginal wall 6 betweenthe incisions 21 and 22 is carefully separated from the endopelvicfascia 8 forming a triangular flap 24. The vaginal wall flap 24 can beused as a tractor to pull the operative field into better view. With theflap 24 in the position shown, it will be noted that a triangularincision, generally indicated at 25, results.

While incisions of other configurations can be used, the above describedtriangular incision 25 has certain advantages. First of all, the vaginalwall edges may be trimmed of excess material having been stretched byprolapse. Furthermore, the endopelvic fascia has been left intact withminimal damage to the local nerve supply to the urethra and bladder, andwith little damage to the blood supply of the endopelvic fascia.

The endopelvic fascia attachment to the vaginal epithelium having beenseparated, the incision 25 may be stretched to a more open position andheld in that position by retractors, or temporary stitches engaging theadjacent drape, as shown at 26 in FIG. 6. At this point, dissection iscarried out laterally to assess the integrity of the lateral attachmentof the endopelvic fascia to each arcus tendineus fascia pelvis 9 and 10.Evaluation is made by palpation and direct visualization. Repairs bysuturing may be made, if required. These sutures are left untied untilthe system of the present invention is in place. Additional repairs mayalso be made, if required.

The system of the present invention can now be put in place. To thisend, a pair of pubic bone anchors (preferably screw anchors orharpoon-type anchors) are located in the pubic bone portions 1 a and 1b. In FIG. 6, an anchor screw 27 is shown being drilled in place in thepubic bone portion 1 b. The site of the pubic bone anchor screw 27 isdetermined by palpating the course of the arcus 10 (see FIG. 2) from theischial spine 13 to the arcus insertion 14 into the posterior/inferioraspect of pubic bone portion 1 b. The anchor screw 27 is provided with apair of sutures 27 a and 27 b (FIG. 7) affixed thereto. The anchor screw27 and its sutures 27 a and 27 b are located within a driver 27 c which,in turn, may be mounted in a surgical drill (not shown). A non-limitingexample of such an anchor screw and driver is taught in U.S. Pat. No.4,632,100. With respect to the sutures 27 aand 27 b, excellent resultshave been achieved with permanent 0 sutures manufactured by Ethicon,Inc. of Summerville, N.J. and sold under the registered trademarkMersilene®.

Anchor screw 27 is placed approximately one fingerbreadth laterally ofthe urethra 4 and approximately 1 cm laterally of the symphysis pubis 2.The anchor screw 27 is then directed to the retropubic areaapproximately 0.5 cm posteriorly and superiorly from the inferior edgeof the ischial ramus. This anchor site is near the insertion point ofthe arcus tendineus to the pubic bone. Once the anchor site is located,the anchor screw 27 is driven into the pubic bone and is set. Thesutures 27 a and 27 b are temporarily laid aside as is shown in FIG. 7.It will be understood that a second anchor screw 28 will be attached tothe pubic bone portion 1 a in precisely the same manner and at thecorresponding position on the pubic bone portion 1 a. This is shown inFIG. 7. The anchor screw 28 is provided with a pair of sutures 28 a and28 b which are laid aside as shown in FIG. 7.

A substantially rectangular patch 29 of surgical mesh, approximately 3cm wide and 6 cm long is then provided. Excellent results have beenachieved by using a surgical mesh manufactured by Ethicon, Inc. ofSummerville, N.J. and sold under the registered trademark Mersilene®.The surgical mesh patch is shown in FIG. 7 at 29. The patch is providedwith longitudinal edges 29 a and 29 b and transverse edges 29 c and 29d. The mesh 29 is laid upon the endopelvic fascia 8 with itslongitudinal edges 29 a and 29 b extending transversely of the urethra 4beneath the endopelvic fascia 8. Four permanent sutures are used totransfix the mesh 29 along the lateral borders of the urethra at theedges 29 a and 29 b of mesh 29. These sutures are shown at 30, 31, 32and 33 in FIG. 7. The sutures are so positioned as to allow a slighttrough-like space between the mesh 29 and the endopelvic fascia 8 andurethra 4. This trough-like space prevents undue tension on the urethraby the mesh when the mesh is formed into a sling, as will be apparenthereinafter. Excellent results were achieved when the sutures 30-33constituted permanent 000 sutures manufactured by Ethicon, Inc. ofSummerville, N.J. and sold under the registered trademark Ethibond®. Itwill further be noted in FIG. 7 that the mesh 29, from longitudinal edge29 a to longitudinal edge 29 b extends along the above-describedintermediate 60% of the length of the urethra 4, as indicated by thepoints 4 a and 4 b shown in FIG. 7.

Reference is now made to FIG. 8. In this Figure, it is shown that thepermanent anchor sutures 27 a and 27 b of anchor screw 27 are woventransversely of the mesh 29 in opposite directions between thelongitudinal mesh edges 29 a and 29 b, and inset from the transversemesh edge 29 d. In a similar fashion, the anchor sutures 28 a and 28 bare woven transversely of mesh 29 in opposite directions between thelongitudinal edges 29 a and 29 b of the mesh, and inset from thetransverse mesh edge 29 c. The placement of the anchor sutures throughthe mesh is determined by placing upward tension on the mesh undercystoscopic guidance to determine the approximate tension required forurethral coaptation from each end of the mesh. As is shown in FIGS. 9and 10, the sutures 27 a and 27 b and sutures 28 a and 28 b are tied ina bilateral fashion to their respective points of attachment to thepubic bone portions 1 a and 1 b so that the transverse edges 29 c and 29d are gathered and are substantially adjacent the pubic bone. Thiscauses the mesh 29 to be transformed into a sling, the ends of which aresubstantially adjacent the pubic bone.

Thereafter, the repair sutures for attaching the endopelvic fascia tothe arcus tendineus fascia pelvis 9 and/or 10 are tied sequentially. Anymid-line or transverse defects are noted and repaired. Additionalrepairs may be made depending upon the requirement of the individualpatient. Then, the triangular flap 24 is removed and the cut edges ofthe anterior vaginal wall are approximated with absorbable 00polyglycolic sutures in a running fashion. At this point, the cul-de-sacand posterior vaginal segment defects are repaired. Cystoscopicexamination of the urethra and the urethral orifices with indigo carminedye are performed. Bladder drainage is provided by a suprapubiccystotomy.

Prior art incontinence procedures involving the use of a sling haveenjoyed excellent surgical success rates. They have, on the other hand,been plagued with numerous drawbacks including voiding dysfunction,urinary retention, detrusor instability, infection, and erosion of thesling material. A number of these problems are, in all likelihood,related to difficulty in achieving the proper tension of the sling.

The system of the present invention (i.e. the anchor screws 26 and 28and their placement, the sutures 26 a, 26 b, 28 a and 28 b and the sling29 and its placement) is characterized by a number of advantages (seeFIG. 11). It is generally believed (as indicated above) that urethralhypermobility is caused by deficiencies in the arcus tendineus fasciapelvis and the pubourethral ligaments. In addition, the pubourethralligaments are subject to stretching or elongation. None of thesedamaged, or elongated, or deficient muscular and fascial paraurethraltissues is used to supply the support and stabilization provided by thesystem of the present invention. The system of the present inventiondoes not hyperelevate the urethra (see FIG. 10) by attachment to thesuperior border of the pubis, to Cooper's ligament or to the rectusabdominus fascia. It is to be noted that in the normal continent female,the urethral position is never found to be hyperelevated (see FIG. 1).By suturing the mesh sling of the present invention to anchor screwslocated, as described above, to either side of the symphysis pubis inthe retropubic area posteriorly and at about 0.5 cm superiorly of theinferior edge of the ischial ramus, such hyperelevation is precluded.The sutures that connect the mesh sling to the anchor screws are,themselves, short which not only assists in developing the propertension, but also minimizes lateral movement cause by intraabdominalpressure. Such movement is characteristic of long length sutures. Inaddition, it will be noted that the sling of the present inventiondiffers from the pubourethral ligaments primarily in that the slingpasses about and behind the urethra, rather than being attached to theurethra sides. However, sutures 30 through 33 simulate an attachment tothe urethra sides. Those portions of the sling between each anchor andits respective pair of sutures 30-32 and 31-33 bear most of the supportload and closely simulate the pubourethral ligaments. As a result ofthis, the sling not only serves much the same purpose as thepubourethral ligaments, but also serves much the same purpose as theendopelvic fascia and the anterior vaginal wall in a healthy woman. Thesling engages the urethra and stabilizes it by passing about theabove-described intermediate 60 percent of the urethra, believed to bethe primary continence control portion of the urethra. It has been foundthat repair of other site-specific defects of genital prolapse correctsonly those defects and does not alter the incontinence mechanism. Forexample, paravaginal repairs of the endopelvic fascia from one arcus tothe other can only be expected to correct the protrusion causing acystourethrocele. If the pubourethral ligaments are damaged, theirability to limit urethral descent with increasing intraabdominalpressures will remain impaired no matter how tight the endopelvic fasciais stretched from one arcus to the other.

Finally, the procedure of the present invention is a relatively simpleone and, as indicated above, proper tension on the sling is far easierto determine than in prior art procedures.

The present invention has been described in the terms of vaginalinstallation of the system of the present invention. At this time, thisis the preferred procedure. Nevertheless, it will be understood that thesystem of the present invention could be installed abdominally orlaproscopically.

Reference is now made to FIG. 12 which illustrates another embodiment ofthe surgical mesh member which serves as a urethral sling. The meshmember is generally indicated at 34 and preferably is made of the samematerial described with respect to the surgical mesh member 29 of FIG.7. The surgical mesh member 34 is provided with a pair of holes 35 and36. The holes 35 and 36 are sized to just nicely receive the shanks ofheaded surgical anchor screws.

The procedure for installing the surgical mesh member 34 issubstantially identical to that described with respect to surgical meshmember 29, with the exception that surgical mesh member 34 is not tiedto anchors by sutures. Surgical mesh member 34 is provided with fourpermanent sutures equivalent to sutures 30-33 of FIG. 7 whereby it isattached to the endopelvic fascia 8. Again, the sutures are sopositioned as to allow a slight trough-like space between the mesh 34and the endopelvic fascia 8 and urethra 4. As indicated with respect tosutures 30-33 of FIG. 7, this trough-like space prevents undue tensionon the urethra by the mesh, when the mesh is formed into a sling.

An anchor screw (not shown) is caused to have its shank inserted throughhole 35 in mesh member 34 and is located in the posterior/inferioraspect of the pubic bone portion 1 a. The site of the anchor screw isdetermined in exactly the same manner as that described with respect toanchor screw 27 of FIG. 7. In a similar fashion, the shank of a secondheaded anchor screw is passed through the hole 36 in mesh member 34 andis located in the posterior/inferior aspect of pubic bone portion 1 b.

Preferably, mesh member 34 is provided with more than one pair of holes.In this way, the surgeon can select an appropriate pair of holes toachieve the best placement of the gauze member sling 34 when it isattached to the posterior/inferior aspect of the pubic bone portions 1 aand 1 b. To this end, mesh member 34 is shown 5 having a second pair ofholes 37 and 38. As shown in FIGS. 12 and 13, the holes in the mesh arepreferably disposed along a longitudinal central axis extending betweenthe ends of the mesh.

Preferably, the holes 35-38 are provided with reinforced stitching abouttheir edges in a manner somewhat similar to button holes.

It is within the scope of the invention to shape the ends of the meshmember. This is illustrated in FIG. 13 wherein the mesh member 39,having a first pair of holes 40-41 and a second pair of holes 42-43, isprovided with somewhat pointed ends 44 and 45. It will be understoodthat the ends may be otherwise shaped. For example, they could bearcuate or rounded.

The mesh sling elements 34 and 39 of FIGS. 12 and 13 tend to simplifythe surgical procedure since it is no longer necessary to weave pairs ofsutures transversely of the mesh member ends as shown in FIG. 8, and totie these sutures as shown in FIG. 9. The number of pairs of holes inthe mesh elements 34 and 39 does not constitute a limitation of thepresent invention. Excellent results can be achieved using gauzeelements 34 or 39 having a length of about 6 centimeters and a width ofabout 3 centimeters.

As used herein and in the claims such works as “uppermost”, “lowermost”,“right”, “left”, and the like are used in conjunction with the drawingsfor clarity.

Modifications may be made in the invention without departing from thespirit of it. For example, throughout the specification, the sling ofthe present invention has been described as a mesh sling. It will beunderstood by one skilled in the art that the sling could also be madeof other acceptable man-made materials, or of autologous fascia orcadaveric fascia.

Furthermore, while the system and method of the present invention aredescribed in their application to women, they could also be applied tomen, as well.

What is claimed is:
 1. A method for treating recurrent female urinaryincontinence comprising: positioning a pair of bone anchors in the pubicbone in spaced apart relationship; positioning a sling around theurethra; and, securing the sling to the bone anchors.
 2. The method ofclaim 1 wherein step of securing the sling to the bone anchors includessecuring the sling such that end edges of the sling are substantiallyadjacent the bone anchors.
 3. The method of claim 1 wherein the step ofpositioning the bone anchors comprises placing the bone anchors on aposterior side of the pubic bone.
 4. The method of claim 3 wherein thestep of positioning the bone anchors comprises placing the bone anchorsnear the point where the arcus tendineus attaches to the pubic bone. 5.The method of claim 1 wherein the bone anchors are introduced into thebone through a vaginal incision.
 6. The method of claim 1 wherein saidsling is passed behind and about the intermediate 60% portion of theurethra from the lower 20% portion to the upper 20% portion of theurethra.
 7. The method of claim 6 including transfix the sling toparaurethral tissue.
 8. The method of claim 1 including securing thesling to the bone anchor with sutures.
 9. The method of claim 8 whereinsaid sling includes a pair of end edges; said method including weaving apair of said anchor sutures through each of said sling edges inset fromsaid end edges thereof.
 10. The method of claim 9 including weaving theanchor sutures of each pair of sutures in opposite directionstransversely through said surgical mesh sling.
 11. A pubic bone-mountedurethra stabilization and support system for the long term cure ofrecurrent female urinary incontinence, said system comprising a pair ofanchors adapted to be affixed to the pubic bone; a sling adapted to bepassed behind and about the said urethra and the endopelvic fascia,sutures which engage the sling and affix the sling to the anchors torestore, support and stabilize functional urethral continence anatomyand to prevent urethral descent under intra-abdominal pressure.
 12. Theurethra stabilization and support system of claim 11 wherein the anchorsare affixed to the posterior/inferior pubic bone to either side of thesymphysis pubis.
 13. The urethra stabilization and support system ofclaim 12 wherein the anchors are affixed to the pubic bone near at thepoint of attachment of the arcus tendineus to the pubic bone.
 14. Theurethra stabilization and support system of claim 11 wherein the slingcomprises surgical mesh.
 15. A method of providing a long term cure forrecurrent female urinary incontinence caused by a hypermobile urethracomprising repositioning the urethra in a normal anatomic position andsupporting it in its normal anatomic position.
 16. The method of claim15 including positioning a sling around the urethra and securing thesling to the pubic bone near the point of attachment of the arcustendineus to the pubic bone.
 17. The method of claim 16 includingtransfixing the sling along the lateral borders of the urethra at thesling's upper and lower borders to the paraurethral tissue.
 18. Themethod of claim 16 including inserting bone anchors into the pubic bonenear the point of attachment of the arcus tendineus to the pubic bone.19. The method of claim 18 including introducing the bone anchor intothe pubic bone transvaginally.
 20. The method of claim 18 whereinsutures are secured to the bone anchors; the method including using theanchor sutures to tie the sling to the bone anchors.
 21. The method ofclaim 20 wherein a pair of anchor sutures are attached to each anchor;the method including weaving each thread of each pair of threads throughthe sling in opposite directions to create a draw string effect, thesutures of each pair of sutures bringing opposite edges of said slingtogether when the sutures are tied off.
 22. A minimally invasive methodof treating recurrent female urinary incontinence caused by ahypermobile urethra comprising: locating an anchor site on a surface ofa pubic bone; positioning an anchor at the anchor site; positioning asling around and about the urethra; and securing the sling to the boneanchor.
 23. The method of claim 22 wherein the locating step includeslocating the anchor site on a posterior surface of the pubic bone. 24.The method of claim 23 wherein the locating step includes locating theanchor site on an inferior-posterior aspect of the pubic bone.
 25. Themethod of claim 24 wherein the locating step includes locating a pair ofanchor sites on either side of the symphysis pubis on theinferior-posterior aspect of the pubic bone.